Drill alignment guide

ABSTRACT

A surgical drill alignment guide is disclosed that can provide an accurate trajectory for placement of a bone screw along a longitudinal axis of a bone.

FIELD OF DISCLOSURE

The present disclosure relates to a targeting guide that can be used toprovide an accurate trajectory for placement of a bone screw along alongitudinal axis of a bone.

BACKGROUND

A successful treatment of bone fractures often depend on accurateplacement of k-wires or bone screws for reducing or compressing thefracture. Often, a surgeon must visually estimate the trajectory of adrill bit for drilling a hole along a long axis of a bone to prepare fora k-wire or a bone screw. When these bones are inside the patient's bodysuch as a hand or a foot, visually estimating the trajectory isdifficult. Thus, a drill alignment or a targeting guide that canfacilitate such procedure is desired.

SUMMARY

Disclosed herein is a surgical drill alignment guide that can be used toprovide an accurate trajectory for placement of a bone screw along thelong axis of a bone. One example of such application is for providing anaccurate trajectory for placement of a bone screw along a fifthmetatarsal bone for treating a Jones fracture.

In some embodiments, the surgical drill alignment guide assemblycomprises a first alignment arm having a first end, a second end, and alongitudinal axis extending from the first end to the second end, thefirst end of the first alignment arm having a first through hole forreceiving a first wire, and at least one second through hole providedbetween the first end and the second end for receiving a second wire.

The first through hole extends through the first end of the firstalignment arm in an orthogonal orientation to and intersecting thelongitudinal axis of the first alignment arm. The at least one secondthrough hole extends through the first alignment arm in an orthogonalorientation to the longitudinal axis of the first alignment arm.

A second alignment arm has a first end, a second end, and a longitudinalaxis extending between the first end and the second end. The first endof the second alignment arm is attached to the first end of the firstalignment arm, wherein the second alignment arm is oriented so that itslongitudinal axis is in parallel relation to the longitudinal axis ofthe first alignment arm. A drill guide is attached to the firstalignment arm between the second end and the at least one second throughhole. The drill guide comprises an arm having a hollow shaft thatextends therethrough for receiving and guiding a drill bit or a k-wire.The hollow shaft extends in parallel relation to the longitudinal axisof the first alignment arm and the longitudinal axis of the secondalignment arm. The hollow shaft is in-plane with the first alignmentarm's longitudinal axis in a first plane, and in-plane with the secondalignment arm's longitudinal axis in a second plane, wherein the firstplane and the second plane are orthogonal to each other.

A method of using the drill alignment guide assembly is also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The inventive surgical drill alignment guide assembly of the presentdisclosure will be described in more detail in conjunction with thefollowing drawing figures. The structures in the drawing figures areillustrated schematically and are not intended to show actualdimensions.

FIG. 1A is an isometric view of a surgical drill alignment guideassembly according to an embodiment of the present disclosure.

FIG. 1B is an isometric view of a surgical drill alignment guideassembly according to another embodiment of the present disclosure.

FIG. 2A is a top-down view of the surgical drill alignment guideassembly of FIG. 1A.

FIG. 2B is a top-down view of the surgical drill alignment guideassembly of FIG. 1B.

FIG. 3A is a sectional view of the surgical drill alignment guideassembly of FIGS. 1A and 2A, taken through the sectional line D-D markedin FIG. 2A.

FIG. 3B is a sectional view of the surgical drill alignment guideassembly of FIGS. 1B and 2B, taken through the sectional line DD-DDmarked in FIG. 2B.

FIG. 4A is a side view of the surgical drill alignment guide assembly ofFIGS. 1A and 2A.

FIG. 4B is a side view of the surgical drill alignment guide assembly ofFIGS. 1B and 2B.

FIG. 5A is a sectional view of the surgical drill alignment guideassembly taken through the sectional line B-B marked in FIG. 4A.

FIG. 5B is a sectional view of the surgical drill alignment guideassembly taken through the sectional line BB-BB marked in FIG. 4B.

FIG. 6 is a perspective view of the surgical drill alignment guideassembly of FIG. 1A in its installed position with respect to a humanright foot showing the alignment guide assembly's arrangement with thefifth metatarsal bone.

FIG. 7 is a perspective view of the surgical drill alignment guideassembly of FIG. 1B in its installed position with respect to a humanright foot showing the alignment guide assembly's arrangement with thefifth metatarsal bone.

FIG. 8 is an illustration showing the spatial relationship among thefifth metatarsal bone B1, the first wire W1, the longitudinal axis AA ofthe first alignment arm 10, and the first alignment plane P1 defined bythe first wire W1 and the long axis A of the fifth metatarsal bone B1,according to the present disclosure.

FIG. 9 is an illustration showing the spatial relationship among thefifth metatarsal bone B1, the long axis A of the fifth metatarsal boneB1, the longitudinal axis AAA of the second alignment arm 20, and thesecond alignment plane P2 according to the present disclosure.

FIG. 10 is an illustration showing the components of FIGS. 8 and 9 andshowing the orthogonal relationship between the first alignment plane P1and the second alignment plane P2 according to the present disclosure.

DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. The drawing figures are notnecessarily to scale and certain features may be shown exaggerated inscale or in somewhat schematic form in the interest of clarity andconciseness. In the description, relative terms such as “horizontal,”“vertical,” “up,” “down,” “top” and “bottom” as well as derivativesthereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should beconstrued to refer to the orientation as then described or as shown inthe drawing figure under discussion. These relative terms are forconvenience of description and normally are not intended to require aparticular orientation. Terms including “inwardly” versus “outwardly,”“longitudinal” versus “lateral” and the like are to be interpretedrelative to one another or relative to an axis of elongation, or an axisor center of rotation, as appropriate. Terms concerning attachments,coupling and the like, such as “connected” and “interconnected,” referto a relationship wherein structures are secured or attached to oneanother either directly or indirectly through intervening structures, aswell as both movable or rigid attachments or relationships, unlessexpressly described otherwise. When only a single machine isillustrated, the term “machine” shall also be taken to include anycollection of machines that individually or jointly execute a set (ormultiple sets) of instructions to perform any one or more of themethodologies discussed herein. The term “operatively connected” is suchan attachment, coupling or connection that allows the pertinentstructures to operate as intended by virtue of that relationship. In theclaims, means-plus-function clauses, if used, are intended to cover thestructures described, suggested, or rendered obvious by the writtendescription or drawings for performing the recited function, includingnot only structural equivalents but also equivalent structures.

Referring to FIG. 1A, a surgical drill alignment guide assembly 100 foraligning a drill guide 30 along a longitudinal axis A of a fifthmetatarsal bone is disclosed. The drill alignment guide assembly 100comprises a first alignment arm 10, a second alignment arm 20, and adrill guide 30.

The first alignment arm 10 has a first end 11, a second end 13, and alongitudinal axis AA extending from the first end 11 to the second end13. The second alignment arm 20 has a first end 21, a second end 22, anda longitudinal axis AAA extending from the first end 21 to the secondend 22.

The second alignment arm 20 is attached to the first alignment arm nearor at the first end 11 of the first alignment arm 10. The secondalignment arm 20 is oriented so that its longitudinal axis AAA is inparallel relation to the longitudinal axis AA of the first alignment arm10. Because of this arrangement, when the longitudinal axis AA of thefirst alignment arm is aligned parallel to the longitudinal axis A ofthe fifth metatarsal bone B1, the second alignment arm's longitudinalaxis AAA is also aligned parallel to the longitudinal axis A of thefifth metatarsal bone B1.

The first end 11 of the first alignment arm 10 is configured to attachto a first wire W1 that is placed into a distal portion of the fifthmetatarsal bone perpendicular to the longitudinal axis A of the fifthmetatarsal bone. In some embodiments, the first alignment arm 10 isconfigured so that the attachment between the first alignment arm 10 andthe first wire W1 can be releasably locked so that the position of thefirst alignment arm 10 along the length of the first wire W1 can befixed then unlocked when the drill alignment procedure is completed.

As shown in FIG. 1A, the first end 11 of the first alignment arm 10 isprovided with a through hole 16 that extends through the full thicknessof the first alignment arm 10 for receiving the first wire W1.Preferably, the through hole 16 extends through the first alignment arm10 straight and oriented orthogonal to the longitudinal axis AA of thefirst alignment arm 10. In use, the first wire W1 would be inserted intothe distal end of the fifth metatarsal bone from the lateral side of thepatient's foot such that the first wire W1 is substantiallyperpendicular to the long axis A of the fifth metatarsal bone. Thethrough hole 16 extends through the first alignment arm 10 straight andoriented orthogonal to the longitudinal axis AA of the first alignmentarm 10. This ensures that when the alignment guide 100 is attached tothe first wire W1 by fitting the through hole 16 over the first wire W1,the first wire W1 and the longitudinal axis AA of the first alignmentarm 10 are orthogonal to each other.

The first alignment arm 10 is configured and adapted to be able to lockthe first wire W1 in place in the through hole 16. There are many knownlocking mechanisms that can be employed here such as a CAM lockingmechanism or a set screw arrangement. In the example illustrated inFIGS. 1A, 3A, and 6, the through hole 16 is provided with a setscrew 41for locking the first wire W1 extending through the through hole 16. Asshown in the cross-sectional view in FIG. 3A, the setscrew 41 threadsinto the first end 11 of the first alignment arm 10 orthogonal to thethrough hole 16. Thus, the first wire W1 extending through the throughhole 16 can be locked in position by tightening the setscrew 41 againstthe first wire W1.

The first alignment arm 10 is also provided with at least one secondthrough hole 18A for receiving a second wire W2 that gets placed into amid-foot bone B2 that is associated with the fifth metatarsal bone B1.Like the first through hole 16, the second through hole 18A also extendsthrough the thickness of the first alignment arm 10 orientedperpendicular to the longitudinal axis AA of the first alignment arm 10.This ensures that a second wire W2 inserted through the second throughhole 18A is parallel to the first wire W1 and, in turn, also orthogonalto the long axis A of the fifth metatarsal bone B1. In some embodiments,the first alignment arm 10 is configured to lock the position of thesecond wire W2 placed through the second through hole 18A. The secondwire W2 is for afixing the orientation of the drill alignment guideassembly 100 to the patient's mid-foot bone B2, so the second throughhole 18A is located at an appropriate distance from the first throughhole 16 so that the position of the second through hole 18A reaches thepatient's mid-foot bone B2.

In some embodiments, a plurality of second through holes 18A areprovided as shown in FIGS. 1A and 1B in order to provide a more robustfunctionality to the drill alignment guide 100 in terms of its abilityto accommodate a wide range of patient's foot sizes. The plurality ofsecond through holes 18A are provided side by side along a portion ofthe first alignment arm 10 as shown so that a variety of choices areavailable for the distance between the first through hole 16 and thesecond through hole 18A to accommodate fifth metatarsal bones ofdifferent lengths.

The surgical drill alignment guide 100 can be configured to lock thesecond wire W2 extending through the second through hole 18A. There aremany known locking mechanisms that can be employed here such as a CAMlocking mechanism or a set screw arrangement. In the example illustratedhere, the first alignment arm 10 is provided with a second set screw 42for locking the second wire W2 extending through a through hole 18A. Asshown in the cross-sectional view in FIG. 3A, the setscrew 42 threadsinto the first alignment arm 10 orthogonal to the through hole 18A.Thus, the second wire W2 extending through the through hole 18A can belocked in position by tightening the setscrew 42 against the second wireW2. Where there are more than one second through hole 18A, each of thesecond though hole 18A will be provided with a second set screw 42.

Referring to FIGS. 3A, 3B, the first alignment arm 10 also has aradio-opaque alignment wire 5 provided along the longitudinal axis AA ofthe first alignment arm so that the alignment wire 5 can be used tocheck the alignment of the first alignment arm 10 under a fluoroscope.

The second alignment arm 20 has a first end 21 and a second end 22, anda longitudinal axis AAA extending between the first end and the secondend. The second alignment arm 20 is disposed in parallel relation to andattached to the first alignment arm 10, whereby the longitudinal axisAAA is in parallel relation to the longitudinal axis AA of the firstalignment arm 10. Thus, when the longitudinal axis AA of the firstalignment arm 10 is positioned in an alignment parallel to thelongitudinal axis A of the fifth metatarsal bone B1, the longitudinalaxis AAA of the second alignment arm 20 is also in parallel relationshipto the longitudinal axis A of the fifth metatarsal bone B1.

In some embodiments, the second alignment arm 20 is attached to thefirst alignment arm 10 by a hinge joint 23A. In the example shown inFIGS. 1A and 1B, the first alignment arm 10 has a vertical connectingarm 12 and the second alignment arm 20 is connected to the extensionsection 12 by the hinge joint 23A. The hinge joint 23A is configured toallow the second alignment arm 20 to turn 180° about the hinge jointfrom the position shown in FIGS. 1A and 1B to the position shown in FIG.6. This allows the surgical drill alignment guide assembly 100 to beused on either the left foot or the right foot. For example, in FIG. 6,the surgical drill alignment guide assembly 100 is installed on thepatient's right foot aligning the drill guide 30 with the fifthmetatarsal bone B1 on the right foot. In this configuration, one can seethat the second alignment arm 20 has been flipped over 180° about thehinge 23A from the configuration shown in FIG. 1A. The drill guide 30 isalso connected to the first alignment arm 10 from the opposite side thanthe configuration shown in FIG. 1A.

The same ability to be used either on the left foot or the right foot isapplicable to the embodiments of the drill alignment guide assemblyshown in FIG. 1B and FIG. 7. In FIG. 1B and FIG. 7, the drill guide 30and the second end 13 of the first alignment arm 10 are configured sothat the drill guide 30 attaches to the first alignment arm 10 byfitting its stem 32 through the slot 14B in a vertical direction ratherthan the sideways engagement in the embodiments of FIG. 1A and FIG. 6.

The vertical connecting arm 12 positions the second alignment arm 20 adistance Y above the longitudinal axis AA of the first alignment arm 10.The distance Y is a distance that is sufficiently large to allow thesecond alignment arm 20 to be positioned above the patient's fifthmetatarsal bone without contacting or interfering with the patient'sfoot.

In the embodiments illustrated in FIGS. 1A and 1B, the verticalconnecting arm 12 extends from the first end 11 of the first alignmentarm 10. However, the vertical connecting arm 12 can be connected to thefirst alignment arm 10 anywhere on the first alignment arm 10 as long asthe second alignment arm 20 can be positioned above the fifth metatarsalbone B1 somewhere along the length of the fifth metatarsal bone B1 onthe dorsal side of the patient's foot or below the fifth metatarsal boneB1 somewhere along the length of the fifth metatarsal bone B1 on theanterior side of the patient's foot. Whether the alignment procedure iscarried out from the dorsal side or the plantar side of the patient'sfoot is at the discretion and preference of the surgeon but the drillalignment guide assembly 100 of the present disclosure is configured tobe used in either direction.

The second alignment arm 20 is connected to the vertical connecting arm12 by a connecting portion 23. The connecting portion 23 extends awayfrom the vertical connecting arm 12 so that the longitudinal axis AAA ofthe second alignment arm 20 is at a distance X from the vertical planeD1 defined through the center of the vertical connecting arm 12 and thelongitudinal axis AA of the first alignment arm 10. The center of thevertical connecting arm 12 here refers to the middle of the thickness ofthe vertical connecting arm 12.

Referring to FIGS. 1A, 1B, 2A, and 2B, the drill guide 30 is attached tothe first alignment arm 10 between the second end 13 and the at leastone second through holes 18A. The drill guide 30 comprises an arm 34having a hollow shaft 35 for receiving and guiding a drill bit or ak-wire. The hollow shaft 35 extends through the length of the drillguide arm 34 in parallel relation to the longitudinal axis AA of thefirst alignment arm 10 and the longitudinal axis AAA of the secondalignment arm 20.

In some embodiments, the drill guide 30 is slidably attached to thefirst alignment arm 10 so that the drill guide 30 can be moved along thelongitudinal axis AA of the first alignment arm 10 and locate it at adesired position along the first alignment arm 10. The connectionbetween the drill guide 30 and the first alignment arm is configured tobe able to lock the drill guide 30 at a desired position.

The drill guide 30 can be attached to the first alignment arm 10 in anysuitable configuration. The example in FIGS. 1A, 2A, 3A, 4A, 5A, and 6show an embodiment where the drill guide 30 is attached to the firstalignment arm 10 in a slidable manner through a slot 14 that isaccessible from the side of the first alignment arm 10. The drill guide30 has a stem portion 31 (labeled in FIG. 2A) that extends through theslot 14 and has a male threaded portion 32 onto which a female threadednut 43 engages to lock the drill guide 30 in place. The stem portion 31is configured to position the hollow shaft 35 of the drill guide 30 atthe distance X from the longitudinal axis AA of the first alignment arm10.

In this example, the stem portion 31 is provided with bump stoppers 33to maintain the fixed distance X. (See FIG. 1A). Here, the distance Xbetween the hollow shaft 35 and the longitudinal axis AA, we arereferring to the distance between the central axis of the hollow shaft35 (having a cylindrical shape) and the longitudinal axis AA. Thisensures that the second alignment arm 20 can be used to align the drillguide 30 to the long axis A of the fifth metatarsal bone B1. Theattachment between the drill guide 30 and the first alignment arm 10 isconfigured so that the hollow shaft 35 of the drill guide 30 is inparallel relation with the longitudinal axis AA of the first alignmentarm 10 and also in the plane P1 defined by the longitudinal axis AA andthe first wire W1 extending through the through hole 16. (See FIG. 8).

FIGS. 1B, 2B, 3B, 4B, 5B, and 7 show an embodiment where the drill guide30 is attached to the first alignment arm 10 in a slidable mannerthrough a slot 14B that is accessible from the top side of the firstalignment arm 10. In this embodiment, the drill guide 30 has a stemportion 31 (labeled in FIG. 2B) that extends under the slot 14B and hasa male threaded portion 32 that extends through the slot 14B onto whicha female threaded nut 43 engages to lock the drill guide 30 in place.The stem portion 31 has an appropriate length to maintain the hollowshaft 35 at the distance X from the longitudinal axis AA of the firstalignment arm 10. In this example the stem portion 31 extends under theslot 14B. Although the stem portion 31 extends under the slot 14B, thestem portion 31 is configured to maintain the hollow shaft 35 in thesame plane P1 defined by the longitudinal axis AA and the first wire W1extending through the through hole 16. (See FIG. 8). In the particularexample shown in FIGS. 1B and 4B, the stem portion 31 has a jog 31A(labeled in FIG. 4B) that extends the stem portion 31 under the slot14B.

In some embodiments of the surgical drill alignment guide assembly, thesecond alignment arm 20 has an alignment wire 25 provided therein andextends along the second alignment arm's longitudinal axis AAA. Thealignment wire 25 is radio-opaque so that it is visible underfluoroscopy for checking the alignment of second alignment arm 20.Because the alignment wire 25 is positioned along the longitudinal axisAAA, the alignment wire 25 represents the longitudinal axis AAA underthe fluoroscope.

In some embodiments, the drill guide 30 is attached to the secondalignment arm 20. Regardless of whether the drill guide 30 is attachedto the first alignment arm 10 or the second alignment arm 20, the drillguide 30 and the second alignment arm 20 are arranged so that the hollowshaft 35 is in the same plane as the longitudinal axis AAA of the secondalignment arm 20, represented by the alignment wire 25 and in the sameplane as the longitudinal axis AA of the first alignment arm 10,represented by the alignment wire 5.

As shown in FIGS. 1A and 1B, the first alignment arm 10 and the secondalignment arm 20 are arranged so that the longitudinal axis AAA isplaced at a distance X from a plane D2 that contains the longitudinalaxis AA of the first alignment arm 10. The structure of the drill guide30 is configured so that the hollow shaft 35 is also placed at thedistance X from the plane D2 and the hollow shaft 35 is in a plane D1that is orthogonal to the plane D2 and intersects the plane D2 along thelongitudinal axis AA. This means that the longitudinal axis AAA of thesecond alignment arm 20 and the hollow shaft 35 are both lie in a planeD3 that is parallel to the plane D2 and orthogonal to the plane D1.Since the hollow shaft 35 has a cylindrical shape, when the presentdisclosure refers to the position of the hollow shaft 35, it isreferring to the position of the longitudinal axis of the hollow shaft35. This configuration among the first alignment arm 10, the secondalignment arm 20, and the drill guide 30, enables a surgeon to use thesurgical drill alignment guide assembly 100 to drill along the long axisA of a fifth metatarsal bone of a patient.

Referring to FIGS. 8-10, in order to assist in describing the spatialalignment of the surgical drill alignment guide assembly 100 with thelong axis A of a fifth metatarsal bone B1, we first define two alignmentplanes P1 and P2 that are orthogonal to each other. Referring to FIG. 8,the first alignment plane P1 is a plane that is defined by the long axisA of the fifth metatarsal bone B1 and the first wire W1 that is placedinto the distal end of the fifth metatarsal bone B1 where the first wireW1 is substantially orthogonal to the long axis A of the fifthmetatarsal bone B1. In other words, the long axis A and the first wireW1 lie in the first alignment plane P1. Referring to FIGS. 9 and 10, thesecond alignment plane P2 is orthogonal to the first plane P1 andintersects the first alignment plane P1 along the long axis A of thefifth metatarsal bone B1. In otherwords, the long axis A of the bone B1lies in both planes P1 and P2.

Because the hollow shaft 35 is in the same first alignment plane P1 asthe longitudinal axis AA of the first alignment arm 10, the hollow shaft35 and the alignment wire 5 (of the first alignment arm 10) are in thesame first plane P1. It should be noted that FIG. 10 does not show thealignment wire 5. However, the longitudinal axis AA of the firstalignment arm 10 represents the location of the alignment wire 5 withrespect to the first plane P1 because the alignment wire 5 is providedin the first alignment arm 10 along the first alignment arm'slongitudinal axis AA,

Some methods for using the drill alignment guide is also disclosed. Insome embodiments, the method comprises the following steps. (a) Thefirst wire W1 is inserted into a distal portion of a first bone B1 of apatient's foot or a hand with the first wire W1 oriented substantiallyorthogonal to the long axis A of the first bone B1. The point of entryfor the first wire W1 is visually determined by the surgeon. The firstwire W1 can either intersect and extends through the long axis A orextends along a trajectory that intersects the long axis A but does notgo through the long axis A depending on the particular situation of thebone fracture or injury being attended to. The first wire W1 and thelong axis A of the first bone B1 together defines the first alignmentplane P1. The first alignment plane P1 is shown in FIG. 8. In otherwords, both the long axis A and the first wire W1 are in-plane in P1.

(b) Next, the first alignment arm 10 is slid over the first wire W1through the first through hole 16 that is provided at the first end 11of the first alignment arm 10. As described above in reference to FIG.1A, the drill alignment guide assembly 100 is configured so that thefirst through hole 16 extends through the first alignment arm 10'slongitudinal axis AA in a direction that is orthogonal to thelongitudinal axis AA, the longitudinal axis AA reside in the plane D2.Therefore, once the first alignment arm 10 is slid over the firs wireW1, the configuration of the drill alignment guide assembly 100 dictatesthat the planes D2 and D3 (shown in FIG. 1A) of the drill alignmentguide assembly 100 are parallel to the second alignment plane P2 shownin FIG. 9.

(c) Next, an incision is made in the patient's foot or a hand near theproximal end of the first bone B1 and the drill guide 30 is moved into aposition so that the tip 37 of the drill guide is contacting theproximal end of the first bone B1. For example, when used on a patient'sfoot for aligning to a fifth metatarsal bone, the drill guide 30 wouldbe contacting the proximal end of the fifth metatarsal bone asappropriate. This example position is illustrated in FIGS. 6 and 7.

(d) Next, the surgeon aligns the second alignment arm 20 to the longaxis A of the first bone B1 under fluoroscopy so that the secondalignment arm's longitudinal axis AAA and the first bone B1's long axisA are in-plane in the second alignment plane P2. This aligning isaccomplished by sliding the drill alignment guide assembly 100 along thefirst wire W1 in the directions illustrated with the arrows S in FIG.10. The radio-opaque alignment wire 25 in the second alignment arm 20 isuseful in this step because the alignment wire 25 representing thelongitudinal axis AAA of the second alignment arm 20 is visible influoroscopy. Preferably, while viewing through a fluoroscope, theparallax cue 27 provided on the second alignment arm 20 is utilized toensure that the surgeon is looking in-plane with the second alignmentplane P2. In this method embodiment, because the drill guide 30 wasplaced in the proximity of the proximal end of the first bone B1, thesecond alignment arm 20 is already substantially close to the desiredalignment position. Thus, only minor adjustments would be necessary toalign the second alignment arm 20 to the long axis A of the first boneB1,

(e) Once the second alignment arm 20 is in alignment with the long axisA, the surgeon inserts a second wire W2 through the at least one secondthrough hole 18A of the first alignment arm and into a second bone B2 ofthe patient. This arrangement is shown in FIGS. 6 and 7. This securesthe parallel alignment relationship between the longitudinal axis AA ofthe first alignment arm 10 and the long axis A of the first bone B1.

(f) Next, the surgeon visually aligns the longitudinal axis AA of thefirst alignment arm 10 with the long axis A of the first bone B1 in thefirst alignment plane P1 by adjusting the orientation of the firstalignment arm 10 by pivoting the first alignment arm 10 about the firstwire W1 in the directions R as shown in FIG. 8. In FIG. 8, the pivotingof the first alignment arm's longitudinal axis AA about the first wireW1 is illustrated by the directional arrows R.

(g) Then, the surgeon confirms the alignment between the first alignmentarm 10 and the long axis A of the first bone B1 by fluoroscopy. This isaccomplished by viewing through a fluoroscope along the first alignmentplane P1 to ensure that the longitudinal axis AA of the first alignmentarm 10 is parallel to the long axis A of the first bone B1 in the firstalignment plane P1. Preferably, while viewing through a fluoroscope, theparallax cue 17 provided on the first alignment arm 10 is utilized toensure that the surgeon is looking in-plane with the first alignmentplane P1.

(h) If the longitudinal axis AA is not parallel to the long axis A, thestep (f) is repeated until the first alignment arm 10 is aligned withthe long axis A. When the parallel relationship between the longitudinalaxis AA and the long axis A is achieved, the longitudinal axis AA andthe long axis A are in-plane in the first alignment plane P1.

(i) At this point, the drill guide 30 is properly aligned to the longaxis A of the first bone B1, i.e., aligned in both the first alignmentplane P1 and the second alignment plane P2. Thus, a k-wire can bedrilled through the hollow shaft 35 of the drill guide 30 and into thefirst bone B1 along its long axis A.

In some embodiments of the procedure, the first bone is a fifthmetatarsal bone and the second bone is a mid-foot bone.

During this procedure, the surgeon has the option of locking the firstalignment arm 10 to the first wire W1 sometime after the step (h) sothat the arrangement of the first wire W1 and the first alignment arm 10is secured. The surgeon has the option of locking the first alignmentarm 10 to the second wire W2 sometime after the step (h) so that thearrangement of the second wire W2 and the first alignment arm 10 issecured. In other embodiments, the surgeon has the option of locking thefirst alignment arm 10 to the first wire W1 and the second wire W2sometime after the step (h) so that the arrangement of the first wireW1, the second wire W2, and the first alignment arm 10 is secured.

As mentioned above, the configuration of the drill alignment guide 100is such that it can be oriented so that the alignment proceduredescribed above can be conducted with the second alignment arm 20positioned on any side of the patient's body portion being operated on.For example, if the drill alignment guide assembly 100 is being used ona foot, the second alignment arm 20 can be positioned on the dorsal sideof the patient's foot or on the plantar side of the patient's foot.Thus, at this point in the procedure, depending on whether the surgeonchose the dorsal side or the plantar side, the visual alignment of thesecond alignment arm 20 to the long axis A is conducted while viewingthe second alignment arm 20 from the dorsal side or from the plantarside.

A method of using the drill alignment guide assembly 100 according tosome other embodiments will now be described. The method comprises thefollowing steps. (aa) The first wire W1 is inserted into a distalportion of a first bone B1 of a patient's foot or a hand with the firstwire W1 oriented substantially orthogonal to the long axis A of thefirst bone B1. The point of entry for the first wire W1 is visuallydetermined by the surgeon. The first wire W1 can either intersect andextends through the long axis A or extends along a trajectory thatintersects the long axis A but does not go through the long axis Adepending on the particular situation of the bone fracture or injurybeing attended to. The first wire W1 and the long axis A of the firstbone B1 together defines the first alignment plane P1. The firstalignment plane P1 is shown in FIG. 8. In other words, both the longaxis A and the first wire W1 are in-plane in P1.

(bb) Next, the first alignment arm 10 is slid over the first wire W1through the first through hole 16 that is provided at the first end 11of the first alignment arm 10. As described above in reference to FIG.1A, because the first through hole 16 extends through the firstalignment arm 10's longitudinal axis AA in a direction that isorthogonal to the longitudinal axis AA, the configuration of thealignment guide assembly 100 dictates that the longitudinal axis AAreside in the plane D2 and that the plane D2 and the second alignmentplane P2 (See FIG. 9) are now parallel to each other. while sharing thefirst wire W1 as the pivot.

(cc) Next, the surgeon visually aligns the first alignment arm 10 withthe long axis A of the first bone B1 by pivoting the first alignment arm10 about the first wire W1 in the directions shown by the arrows R shownin FIG. 8, until the first alignment arm's longitudinal axis AA and thefirst bone's long axis A are in-plane in the first alignment plane P1.In FIG. 8, the pivoting of the longitudinal axis AA about the first wireW1 is illustrated.

(dd) Then, the surgeon confirms the alignment between the firstalignment arm 10 and the long axis A of the first bone B1 byfluoroscopy. This is accomplished by viewing through a fluoroscope alongthe first alignment plane P1 to ensure that the longitudinal axis AA ofthe first alignment arm 10 is parallel to the long axis A of the firstbone B1. Preferably, while viewing through a fluoroscope, the parallaxcue 17 provided on the first alignment arm 10 is utilized to ensure thatthe surgeon is looking in-plane with the first alignment plane P1.

(ee) If the longitudinal axis AA is not parallel to the long axis A, thesteps (cc) and (dd) are repeated until the first alignment arm 10 isaligned with the long axis A. When the parallel relationship between thelongitudinal axis AA and the long axis A is achieved, the longitudinalaxis AA and the long axis A are in-plane in the first alignment planeP1.

(ff) Once the first alignment arm 10 is in alignment with the long axisA, the surgeon inserts a second wire W2 through the at least one secondthrough hole 18A of the first alignment arm and into a second bone B2 ofthe patient. This arrangement is shown in FIGS. 6 and 7. This is tosecure the parallel alignment relationship between the longitudinal axisAA of the first alignment arm 10 and the long axis A.

(gg) Next, the surgeon visually aligns the second alignment arm 20 tothe long axis A of the first bone B1 by sliding the whole drillalignment guide assembly 100 along the lengths of the first and secondwires W1 and W2 while looking down at the second alignment arm 20. Thisalignment step is for positioning the longitudinal axis AAA of thesecond alignment arm 20 in the second alignment plane P2. In FIG. 10,the sliding motion of the drill alignment guide assembly 100 isillustrated with the arrows S.

As mentioned above, the configuration of the drill alignment guide 100is such that it can be oriented so that the alignment proceduredescribed above can be conducted with the second alignment arm 20positioned on any side of the patient's body portion being operated on.For example, if the drill alignment guide 100 is being used on a foot,the second alignment arm 20 can be positioned on the dorsal side of thepatient's foot or on the plantar side of the patient's foot. Thus, atthis point in the procedure, depending on whether the surgeon chose thedorsal side or the plantar side, the visual alignment of the secondalignment arm 20 to the long axis A is conducted while viewing thesecond alignment arm 20 from the dorsal side or from the plantar side.

(hh) Next, the alignment between the second alignment arm 20 and thelong axis A of the first bone B1 is verified using fluoroscopy. Theradio-opaque alignment wire 25 in the second alignment arm 20 is usefulin this step because the alignment wire 25 is visible in fluoroscopy.Preferably, while viewing through a fluoroscope, the parallax cue 27provided on the second alignment arm 20 is utilized to ensure that thesurgeon is looking in-plane with the second alignment plane P2.

(ii) If the alignment is not as desired and needs adjusting, the steps(gg) and (hh) are repeated until the second alignment arm 20 is alignedwith the long axis A of the first bone B1.

(jj) Next, an incision is made in the patient's foot or a hand near theproximal end of the first bone B1 and the drill guide 30 is moved into aposition so that the tip 37 of the drill guide is contacting theproximal end of the first bone B1. For example, when used on a patient'sfoot for aligning to a fifth metatarsal bone, the drill guide 30 wouldbe contacting the proximal end of the fifth metatarsal bone asappropriate. This example position is illustrated in FIGS. 6 and 7.Because the hollow shaft 35 of the drill guide 30 is in-plane with thelongitudinal axis AA in the plane D1 and in-plane with the longitudinalaxis AAA, the hollow shaft 35 will be in axial alignment with the longaxis A of the first bone B1.

During this procedure, the surgeon has the option of locking the firstalignment arm 10 to the first wire W1 sometime after the step (ii) sothat the arrangement of the first wire W1 and the first alignment arm 10is secured. The surgeon has the option of locking the first alignmentarm 10 to the second wire W2 sometime after the step (ii) so that thearrangement of the second wire W2 and the first alignment arm 10 issecured. In other embodiments, the surgeon has the option of locking thefirst alignment arm 10 to the first wire W1 and the second wire W2sometime after the step (ii) so that the arrangement of the first wireW1, the second wire W2, and the first alignment arm 10 is secured.

At this point, the long axis A, the longitudinal axis AA, and thelongitudinal axis AAA are in the desired alignment relative to eachother. This alignment is illustrated in FIG. 10 where the longitudinalaxis AA and the long axis A are in-plane in the first alignment plane P1and the longitudinal axis AAA and the long axis A are in-plane in thesecond alignment plane P2.

The method can further comprise a step of locking the drill guide 30 inplace. In the examples illustrated here, the drill guide 30 can belocked in place by tightening the locking nut 43. After the drill guide30 is locked in place a k-wire is inserted or thrown through the hollowshaft 35 of the drill guide 30 and into the first bone B1 following thetrajectory set by the drill guide 30. Then, a drill bit is insertedthrough the hollow shaft 35 over the k-wire for drilling into the firstbone.

In some embodiments, the first bone B1 is a fifth metatarsal bone of apatient and the second bone B2 is a mid-foot bone associated with thefifth metatarsal bone. In some embodiments, the first bone B1 is a firstmetatarsal bone of a patient and the second bone B2 is a mid-foot boneassociated with the first metatarsal bone.

According to some other embodiments of the method, the second alignmentarm 20 can be aligned with the long axis A of the first bone B1 first.Then, the first alignment arm 10 can be aligned with the long axis A ofthe first bone B1 before the second wire W2 is secured to the secondbone B2. Accordingly, this alternate method comprises: (aaa) insertingthe first wire into a first bone of a patient (the first wire can beinserted either into the distal portion or into the proximal portion ofthe first bone) wherein the first wire is substantially orthogonal tothe first bone's long axis; (bbb) sliding the first alignment arm overthe first wire through the first through hole; (ccc) aligning the secondalignment arm to the long axis of the first bone so that the secondalignment arm's longitudinal axis and the first bone's long axis arein-plane in the second alignment plane; (ddd) confirming the alignmentbetween the second alignment arm and the long axis of the first bone byfluoroscopy; (eee) repeating (ccc) and (ddd) if necessary, until thesecond alignment arm is aligned with the long axis of the first bone;(fff) aligning the first alignment arm to the long axis of the firstbone so that the first alignment arm's longitudinal axis and the firstbone's long axis are in-plane in the first alignment plane; (ggg)confirming the alignment between the first alignment arm and the longaxis of the first bone by fluoroscopy; (hhh) repeating (fff) and (ggg)if necessary, until the first alignment arm is aligned with the longaxis; (iii) inserting the second wire through the at least one secondthrough hole of the first alignment arm and into a second bone of thepatient; (jjj) locking the first alignment arm to the first wire so thatthe arrangement of the first wire and the first alignment arm is fixed;(kkk) locking the first alignment arm to the second wire so that thearrangement of the second wire and the first alignment arm is fixed; and(lll) moving the drill guide into place so that the hollow shaft of thedrill guide is alignment with the long axis of the first bone. In someembodiments of this procedure, the steps (jjj) and (kkk) can be optionaland the surgeon can opt to perform the steps (jjj) and (kkk)individually sometime after the step (iii) or perform the steps (jjj)and (kkk) together sometime after step (iii). In steps (ddd) and (ggg)in this embodiment, while viewing through a fluoroscope, the parallaxcue 17 provided on the first alignment arm 10 and the parallax cue 27provided on the second alignment arm 20 are utilized to ensure that thesurgeon is looking in-plane with the associated first alignment plane P1and the second alignment plane P2.

Although the devices, kits, systems, and methods have been described interms of exemplary embodiments, they are not limited thereto. Rather,the appended claims should be construed broadly, to include othervariants and embodiments of the devices, kits, systems, and methods,which may be made by those skilled in the art without departing from thescope and range of equivalents of the devices, kits, systems, andmethods.

1-10. (canceled)
 11. A surgical method for using a drill alignmentguide, the method comprising: (a) inserting a first wire into a distalportion of a first bone of a patient wherein the first wire is orientedsubstantially orthogonal to the first bone's long axis, whereby thefirst wire and the long axis of the first bone define a first alignmentplane; (b) providing a drill guide that includes a first and a secondalignment arm and sliding the first alignment arm over the first wirethrough a first through hole; (c) making an incision near the proximalend of the first bone and positioning the drill guide so that a tip ofthe drill guide is contacting the proximal end of the first bone; (d)aligning the second alignment arm to the long axis of the first boneunder fluoroscopy so that the second alignment arm's longitudinal axisand the first bone's long axis are in-plane in a second alignment planethat is orthogonal to the first alignment plane; (e) inserting a secondwire through the at least one second through hole of the first alignmentarm and into a second bone of the patient thus securing the parallelalignment relationship between the longitudinal axis of the firstalignment arm and the long axis of the first bone; (f) visually aligningthe longitudinal axis of the first alignment arm with the long axis ofthe first bone in the first alignment plane by adjusting the orientationof the first alignment arm by pivoting the first alignment arm about thefirst wire; (g) confirming the alignment between the longitudinal axisof the first alignment arm and the long axis of the first bone byfluoroscopy; and (h) repeating the step (f) if the longitudinal axis ofthe first alignment arm is not aligned with the long axis of the firstbone.
 12. The surgical method of claim 11, further comprising a step (i)of drilling a k-wire through the hollow shaft of the drill guide andinto the first bone.
 13. The surgical method of claim 11, furthercomprising a step of locking the first alignment arm to the first wiresometime after the step (g) so that the arrangement of the first wireand the first alignment arm is fixed.
 14. The surgical method of claim11, wherein the first bone is a fifth metatarsal bone and the secondbone is a mid-foot bone.
 15. The surgical method of claim 11, furthercomprising the step of locking the drill guide in place after the step(h).
 16. The surgical method of claim 11, wherein in step (d), aparallax cue provided on the second alignment arm is utilized to ensurethat the fluoroscopy is being taken in-plane with the second alignmentplane.
 17. The surgical method of claim 11, wherein in step (g), aparallax cue provided on the first alignment arm is utilized to ensurethat the fluoroscopy is being taken in-plane with the first alignmentplane.
 18. A surgical method for using the drill alignment guide, themethod comprising: (a) inserting the first wire into a distal portion ofa first bone of a patient wherein the first wire is substantiallyorthogonal to the first bone's long axis; (b) providing a drill guidethat includes a first and a second alignment arm and sliding the firstalignment arm over the first wire through a first through hole; (c)aligning the first alignment arm to the long axis of the first bone sothat the first alignment arm's longitudinal axis and the bone's longaxis are in-plane in the first alignment plane; (d) confirming thealignment between the first alignment arm and the long axis of the firstbone by fluoroscopy; (e) repeating (c) and (d) if necessary, until thefirst alignment arm is aligned with the long axis of the first bone; (f)inserting a second wire through the at least one second through hole ofthe first alignment arm and into a second bone of the patient; (g)aligning the second alignment arm to the long axis of the first bone sothat the second alignment arm's longitudinal axis and the first bone'slong axis are in-plane in the second alignment plane; (h) confirming thealignment between the second alignment arm and the long axis of thefirst bone by fluoroscopy; (i) repeating (g) and (h) if necessary, untilthe second alignment arm is aligned with the long axis of the firstbone; (j) moving the drill guide into place so that the hollow shaft ofthe drill guide is alignment with the long axis of the first bone. 19.The surgical method of claim 18, further comprising a step of lockingthe first alignment arm to the first wire sometime after the step (i) sothat the arrangement of the first wire and the first alignment arm isfixed.
 20. The surgical method of claim 18, further comprising a step oflocking the first alignment arm to the second wire sometime after thestep (i) so that the arrangement of the second wire and the firstalignment arm is fixed.
 21. The surgical method of claim 18, furthercomprising a step of locking the first alignment arm to the first wireand the second wire sometime after the step (i) so that the arrangementof the first wire, the second wire, and the first alignment arm isfixed.
 22. The surgical method of claim 18, wherein the first bone is afifth metatarsal bone and the second bone is a mid-foot bone.
 23. Thesurgical method of claim 18, further comprising the step (k) of lockingthe drill guide in place after the step (j).
 24. The surgical method ofclaim 23, further comprising the step (l) of throwing a k-wire throughthe drill guide and into the first bone.
 25. The surgical method ofclaim 24, further comprising the step (m) of drilling over the k-wire.26. The surgical method of claim 18, wherein in step (d), a parallax cueprovided on the first alignment arm is utilized to ensure that thefluoroscopy is being taken in-plane with the first alignment plane. 27.The surgical method of claim 18, wherein in step (h), a parallax cueprovided on the second alignment arm is utilized to ensure that thefluoroscopy is being taken in-plane with the second alignment plane. 28.A surgical method for using the drill alignment guide, the methodcomprising: (a) inserting the first wire into a distal portion of afirst bone of a patient wherein the first wire is substantiallyorthogonal to the first first bone's long axis; (b) providing a drillguide that includes a first and a second alignment arm and sliding thefirst alignment arm over the first wire through a first through hole;(c) aligning the second alignment arm to the long axis of the first boneso that the second alignment arm's longitudinal axis and the firstbone's long axis are in-plane in the second alignment plane; (d)confirming the alignment between the second alignment arm and the longaxis of the first bone by fluoroscopy; (e) repeating (c) and (d) ifnecessary, until the second alignment arm is aligned with the long axisof the first bone; (f) aligning the first alignment arm to the long axisof the first bone so that the first alignment arm's longitudinal axisand the first bone's long axis are in-plane in the first alignmentplane; (g) confirming the alignment between the first alignment arm andthe long axis of the first bone by fluoroscopy; (h) repeating the steps(f) and (g) if necessary, until the first alignment arm is aligned withthe long axis; (i) inserting the second wire through at least one secondthrough hole of the first alignment arm and into a second bone of thepatient; and (j) moving the drill guide into place so that the hollowshaft of the drill guide is alignment with the long axis of the firstbone.
 29. The surgical method of claim 28, further comprising a step oflocking the first alignment arm to the first wire sometime after step(i) so that the arrangement of the first wire and the first alignmentarm is fixed.
 30. The surgical method of claim 28, further comprising astep of locking the first alignment arm to the second wire sometimeafter step (i) so that the arrangement of the second wire and the firstalignment arm is fixed.
 31. The surgical method of claim 28, furthercomprising steps of locking the first alignment arm to the first wireand the second wire sometime after step (i) so that the arrangement ofthe second wire and the first alignment arm is fixed.
 32. The surgicalmethod of claim 28, wherein in step (d), a parallax cue provided on thesecond alignment arm is utilized to ensure that the fluoroscopy is beingtaken in-plane with the second alignment plane.
 33. The surgical methodof claim 28, wherein in step (g), a parallax cue provided on the firstalignment arm is utilized to ensure that the fluoroscopy is being takenin-plane with the first alignment plane.